The present invention relates to an impermeable flexible multicompartment bag for medical use for sterile solutions, and to a method for the preparation of such bags.
In the pharmaceutic industry, and especially in the field of perfusion solutions, impermeable flexible bags are extensively used. Such bags are prepared from polymerized materials which have to meet a wide variety of requirements. Thus, in particular, gas and vapor tightness, transparency, printability and inertness towards the substances they contain are of essential importance. The substances essentially consist of salts and solutions thereof, carbohydrates, amino acids and lipids. They are employed in multicompartment bags, the individual compartments being filled with different components.
DE 44 10 876 A1 relates to a multicompartment bag made of a polymeric material whose bag compartments are formed by welds in the peripheral region and by at least one weld in the intercompartment region, the welds being formed from the polymeric materials facing the compartments.
The polymeric materials facing the compartments are inseparably welded together in the peripheral region, and are welded together in the intercompartment region in such a way that the weld can be ruptured with a force in the range of from 5 to 20 N. The different strengths of the bondings are achieved by varying welding temperatures in the welding process. The layer of the multilayer sheet which faces the compartments, referred to herein as the inner layer, essentially comprises two components, namely a matrix polymer and a phase polymer. The system of matrix and phase polymer is also referred to as a matrix-phase polymer system.
EP 0 619 998 A1 also describes a multicompartment container with a peeling weld. The multilayer comprises at least one radiofrequency-sensitive layer and one inner layer facing the contents of the compartment which is made of a non-radiofrequency-sensitive material. When the layers are subjected to radiofrequency irradiation, the inner, sensitive layer is heated and can thus be welded with the opposite side. As the materials for the heat-sealable layer, an alloy of styrene-ethylene-butylene-styrene (SEBS) and ethylene-propylene copolymer is described. However, this material is very expensive and therefore only conditionally suitable for a product sold on a large scale.
On the other hand, from EP 0 353 193 B1, there is known an impermeable flexible bag for sterile solutions for medical use, in particular a flexible bag for perfusions, characterized by being made of two welded sheets of a multilayer sheet material comprising an 11-aminoundecanoic acid polyamide film bonded by at least one of its faces to a polypropylene film, by means of a polyolefin film, said polypropylene films forming the inner wall of said impermeable flexible bag. Said polypropylene may be either a propylene homopolymer or a copolymerizate of propylene and ethylene.
The object of the present invention is to provide an inexpensive impermeable flexible multicompartment bag for medical use which is suitable for subjecting the substances contained therein to heat sterilization at 121xc2x0 C. , especially to provide a bag which does not require an over bag for clinical applications.